59
Participants
Start Date
June 12, 2024
Primary Completion Date
November 30, 2027
Study Completion Date
December 31, 2027
Carfilzomib
"Induction:~ASCT:20mg/56mg/m2 ,D1,8,15,C2-4; non ASCT: 20mg/36mg/m2 ,D1,8,15,C2-4;~Consolidation:~ASCT: 56mg/m2 ,D1,8,15,C5-6; non ASCT: 36mg/m2 ,D1,8,15,C5-8;~Maintenance:~ASCT: 70mg/m2 ,D1,15; non-ASCT:56mg/m2 ,D1,15 After consolidation therapy, if MRD negativity is sustained for more than 1 year, carfilzomib will be discontinued"
Daratumumab
"28d/Cycle~Induction:~16mg/kg, D1,8,15,22,C 2-3,16mg/kg, D1,15, C4;~Consolidation:~ASCT: 16mg/kg/d, D1,15,C5-6; non ASCT: 16mg/kg/d, D1,15,C5-8;~Maintenance:~16mg/kg, D1,monthly After consolidation therapy, if MRD negativity is sustained for more than 1 year, daratumumab will be discontinued"
Lenalidomide
"28d/Cycle~Induction:~25mg qd d1-21 C2-C4;~Consolidation:~ASCT: 10mg d1-21,C5-6; non ASCT: 25 mg d1-21,C5-8;~Maintenance: 10mgqd D1-21~After consolidation therapy, if MRD negativity is sustained for more than 1 year, lenalidomide monotherapy will be maintained until disease progression"
Dexamethasone
"28d/Cycle~Induction:~ASCT:40mg qd, po/iv,D1,8,15,22,C2-4; non ASCT:20mg qd, po/iv,D1,8,15,22,C2-4;~Consolidation:~ASCT: 40mg qd, po/iv,D1,8,15,22,C5-6; non ASCT:20mg qd, po/iv,D1,8,15,22,C5-8"
VRD for first-cycle induction therapy
"Induction:~C1, 28d/cycle Bortezomib(V):1.3 mg/m2,H,d1、4、8、11; Lenalidomide(R):25mg,po. qd d1-14; Dexamethasone(D):20 mg,po/iv,D1,2, 4,5, 8,9, 11,12。"
RECRUITING
The First Affiliated Hospital of Soochow University, Suzhou
The First Affiliated Hospital of Soochow University
OTHER